<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016051624342N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-04-13</date_registration>
      <primary_sponsor>Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the nurses empowerment  on the quality of care in patient</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the nurses empowerment program on the quality of care in patient, nurses commuincation skill and job stress management in CCU wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of Care in Patient.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 16 hours nurse empowerment workshop in 4 sessions for one day a week for 4 hours each day, in two parts held managing stress and communication skills. Learning approach for presentations using PowerPoint and worksheet exercises are operation. In the two sessions of stress management training will be held 4 hours on one day of the week with the participation of the participants in the use of concrete examples for four hours. In the two sessions of communication skills training will be held 4 hours on one day of the week according to the directory for nurses communication skills (Communication Skills for Nurese) and communicate with the patient in addition examples of the difficult topics of communication skills in CCU for 4 hours. 4 weeks after finishing fourth session, communication skills and stress questionnaire by the nurses and the quality of care by patients is completed. Intervention 2: In the control group there is no intervention, just before and 4 weeks after study, communication skills and stress questionnaires  by nurses and quality of care by patients is completed .</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Sakineh Salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 936 881 3365</telephone>
        <email>s.sakineh.salimi@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vida Shafipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 151 9667</telephone>
        <email>v.shafipour@mazuma.ac.ir; vidashafipour@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for nurses: working in the CCU, having a nursing degree (undergraduate and graduate), at least a yearwork experience, without taking classes to manage job stress and nurses communication skills.&#13;
 Exclusion criteria for nurses: absence in one of the two workshops, leave or transfer to other parts of the CCU or other hospitals, using drugs such as sedatives; anti-depressants; anti-psychotic and anti-anxiety, a psychological crisis in the past 6 months dealing with incidents such as the death of loved ones; accident; divorce and family disputes is. &#13;
Inclusion criteria for patients: being alert, admitted to CCU, the desire to complete the questionnaire, are older than 18 years.&#13;
 Exclusion criteria for patients: have mental illness (depression, schizophrenia, cognitive disorders, personality disorders), blindness and deafness.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z73.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 16 hours nurse empowerment workshop in 4 sessions for one day a week for 4 hours each day, in two parts held managing stress and communication skills. Learning approach for presentations using PowerPoint and worksheet exercises are operation. In the two sessions of stress management training will be held 4 hours on one day of the week with the participation of the participants in the use of concrete examples for four hours. In the two sessions of communication skills training will be held 4 hours on one day of the week according to the directory for nurses communication skills (Communication Skills for Nurese) and communicate with the patient in addition examples of the difficult topics of communication skills in CCU for 4 hours. 4 weeks after finishing fourth session, communication skills and stress questionnaire by the nurses and the quality of care by patients is completed.</i_keyword>
      <i_keyword>In the control group there is no intervention, just before and 4 weeks after study, communication skills and stress questionnaires  by nurses and quality of care by patients is completed .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nurses communication skill and job stress managment. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Communication skills questionnaire (HP-CSS) and nurses job stress questionnaire (NSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of patient care. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Quality of patient care questionnaire (QUALPACS).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-05</approval_date>
        <contact_name>Ethics committee Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem Square. sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
